Companies developing devices for diabetes have to ask a question that companies in other medical device fields don't: what about the users, the people with diabetes? How will they use the device?
Article preview from Start Up - April, 2010
In many ways, executives of start-ups developing insulin pumps have it easy when raising capital. They don't have to sell venture capitalists on the market. Across the world, 220 million people have diabetes (24 million just in the US) and that number is projected to grow to more than 400 million by the year 2030. The product is a pump, a simple technology in an industry rich with untested devices. And the chief therapeutic agent – insulin – is a known treatment that's well-received by physicians and patients alike, at least in terms of effectiveness.
Insulin delivery companies don't need to wrestle with any scientific or clinical unknowns. The goals for managing the disease are clear and so are the roles of drugs and devices designed to achieve those ends. The landmark trial DCCT (Diabetes Control and Complications Trial, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and conducted from 1983-1993) demonstrated that patients with type 1 diabetes who intensively manage their blood glucose levels to avoid excursions beyond a healthy range avoid complications such as retinopathy, kidney damage, and neuropathy.
The strategies for achieving such tight control are also well accepted; patients with diabetes should measure blood glucose levels frequently and eat or add insulin or other drugs as needed to keep blood sugar in a healthy range. New device companies don't need to validate the role of insulin; they need simply show that their devices deliver insulin they way they promise to. At the same time, there are still enormous unmet clinical needs, (and therefore, a role for new products) as evidenced by at least one measure: the staggering amount of money spent by health care systems to manage the costs and complications of diabetes.
But insulin pump start-ups must answer a question that faces few
other device companies. What about the users, the people with diabetes?
Will they use the device? Because if they don't, all the research,
development, funding, and commercial sales teams won't matter one bit:
the device will fail. That's what makes diabetes different from other
medical device segments – the degree to which patient involvement with
their care is directly responsible for outcomes. The contribution of
drugs and devices to treatment success in diabetes wholly depends upon
what patients do with them, and by patients, we mean people, in all the
ways that human beings can be different from one another – different
genetics, co-morbidities, familial support systems, degrees of
motivation, or comfort levels with technologies. Physicians know this
too, and make prescribing decisions based not necessarily on ideal
clinical guidelines, but on practical considerations such as how much
time it might take to train a patient, and what it takes to prevent
patients from coming to harm from a drug like insulin, which, beyond
its therapeutic dosage, can be dangerous.
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